Apparatus for engrafting a blood vessel

ABSTRACT

The present invention relates to an apparatus for deploying and endoluminal prosthesis. The apparatus includes a flexible compressible push rod that allows the catheter to be easily maneuvered through tortuous vessels while providing sufficient deployment force.

BACKGROUND OF THE INVENTION

A. Field of the Invention

The present invention relates to blood vessel graft systems forrepairing aneurysms, and more particularly to a catheter-based graftsystem for repairing aortic aneurysms by deploying a graft within ablood vessel via percutaneous entry into a femoral artery of a patient.

B. Description of the Prior Art

An aortic aneurysm is a very common deteriorating disease typicallymanifested by weakening and expansion of the aorta vessel wall at aregion between the aorto-renal junction and the aorto-iliac junction.Aneurysms affect the ability of the vessel lumen to conduct fluids, andmay at times be life threatening, for instance when rupture of thevessel wall occurs. A standard treatment for repairing an aneurysm is tosurgically remove part or all of the aneurysm and implant a replacementprosthetic section into the vessel, however such surgery is generallypostponed until the aneurysm has grown to a diameter greater than fivecentimeters. With aneurysms over five centimeters in diameter, the riskof complications is greater than the risks inherent in surgical excisionand grafting of the aneurysm. Consequently, aortic aneurysms measuringgreater than five centimeters in diameter, and those showing a rapidincrease in size, are generally surgically removed and grafted as amatter of course, before rupture occurs.

The standard procedure for repairing an aortic aneurysm requires one ortwo days of preparing the large and small intestines prior tohospitalization. The operation itself generally takes one to three hoursto perform, and necessitates several units of blood for transfusion. Thepatient commonly remains hospitalized for several days followingsurgery, and requires as much as three months recuperation time beforereturning to work. Moreover, there remain significantly high rates ofmortality and morbidity associated with the standard procedure. Themortality rate is as high as eight percent, while the morbidity rateincludes incident complications such as blood loss, respiratory tractinfections, wound infections, graft infections, renal failure, andischemia of the bleeding intestine. The mortality and morbidity ratesfor this type of major surgery are also often influenced by the factthat the typical aortic aneurysm patient is elderly and therefore lessable to withstand major surgery, including anesthesia.

Other treatments for repairing an aneurysm involve deploying a graftdevice at the aneurysm site via a catheter traveling through a femoralartery. Conventional tubular aortic replacement sections, however, aregenerally considerably larger in diameter than the femoral artery andtherefore cannot be inserted through the femoral artery lumen to thesite of the aneurysm. Expandable graft devices suitable for catheterdelivery and deployment have been proposed, as in U.S. Pat. Nos.4,140,126 and 4,562,596 by Choudhury and Kornberg, respectively, howeverthe expanding structures of the devices are cumbersome and difficult tooperate.

U.S. Pat. No. 5,104,399 to Lazarus discloses an artificial graft devicehaving staples at proximal and distal ends thereof for fixing the graftwithin the vessel, and a catheter-based deployment system including atubular capsule from which the graft is deployed. The graft is of apreselected cross section and length, and is capable of beingsubstantially deformed so as to accommodate to the interior surface ofthe blood vessel.

The majority of other graft systems, as exemplified by U.S. Pat. No.5,304,220 to Maginot and U.S. Pat. No. 5,151,105 to KwanGett, requireadditional suturing or other methods for securing a graft. Furthermore,once a graft has been placed inside the lumen, adjustment usuallyrequires a major surgical procedure.

Furthermore, the prior art stainless steel or elgialloy stent graftscarry high leakage rates. Moreover, high incidence of fractures havebeen associated with stainless steel stent grafts.

An additional problem with grafts in the public domain is the graftin-folding which causes leakage, migration, and thrombosis. Too, thosegrafts in the public domain such as U.S. Pat. No. 5,507,771 can provideadequate seals only with straight surfaces due to the spring shape andsealing force.

In cases where the aneurysm involves the ipsilateral and contralateraliliac vessels extending from the aorta, it is known to provide agenerally Y-shaped bifurcated graft having a primary limb joining withan ipsilateral limb and a contralateral limb. An example of such agraft, and means for surgically implanting same, are described in U.S.Pat. No. 5,387,235 to Chuter. The surgical procedure taught by Chuterinvolves either surgical isolation of the femoral vessels in the grointo provide direct access to the vessels, or percutaneous entry throughboth ipsilateral and contralateral femoral arteries.

The difficulties involved with traditional surgical procedures andadditional complexities associated with securing grafts make thetreatment of aneurysms a very expensive and lengthy procedure. Thus,there exists a need for a treatment for aneurysms which requires minimalpreparation and outpatient care, and which provides a safe andpercutaneous method for deploying a graft capable of remaining in placewithout additional suturing or stapling for security.

SUMMARY OF THE INVENTION

Therefore, it is an object of the present invention to provide a graftwhich is deployable percutaneously by low-profile deployment means, andwhich provides a leak-proof conduit through the diseased region withoutsuturing or stapling.

It is another object of the present invention to provide a bifurcatedgraft deployable through a single entry site.

It is yet another object of the present invention to provide anadjustable-length extension graft for coupling with a limb of apreviously deployed graft.

It is yet another object of the present invention to provide low-profilegraft deployment means capable of securely deploying a graft viapercutaneous entry.

It is yet another object of the present invention to provide deploymentmeans having inflatable and deflatable balloons for modeling a graftspring portion into conforming fixed engagement with the interiorsurface of a vessel, for dilating a vessel to facilitate insertion, andfor controlling blood flow through a vessel during deployment of agraft.

It is yet another object of the present invention to establish animproved method for securely deploying a graft with minimal incision.

It is yet another object of the present invention to establish a methodfor implanting a graft with low mortality and low morbidity risks topatients.

It is yet another object of the present invention to establish a methodfor implanting a graft which requires less hospital and outpatient carethan required by normal surgical grafting procedures.

It is yet another object of the present invention to establish asingle-entry method for deploying a bifurcated graft.

It is yet another object of the present invention to is provide meansfor easily adjusting or removing an improperly deployed graft.

The present invention relates to an aneurysm repair system characterizedby a graft apparatus which can be placed percutaneously via deploymentmeans at the location of an aneurysm. It will be understood the term“proximal” as used herein means relatively closer to the heart, whilethe term “distal”, as used herein means relatively farther from theheart.

The graft apparatus of the present invention comprises a tubular graftformed of bio-compatible graft material for conducting fluid, and may bein the form of either a straight single-limb graft or a generallyY-shaped bifurcated graft having a primary limb joining with a pair oflateral limbs, namely an ipsilateral limb and a contralateral limb, at agraft junction. A single-limb extension graft having a mating portionfor coupling with a lateral limb of a bifurcated graft and an adjustablelength portion extending coaxially from a distal end of the matingportion is also within the scope of the present invention. The graftmaterial, preferably thin wall woven polyester orpolytetrafluoroethylene (PTFE), is chosen so that the graft is capableof substantially deforming to conform to an interior surface of theblood vessel, and is preferably tapered through a middle portion of eachlimb. Other covering materials may be used, however, includingmicro-porous polyurethane, lycra, or cryogenically preserved explantedveins. The most preferred embodiment for the covering material is Lycraoutside with thin PTFE inside at top proximal section with bare nitinolsinusoidal extension for above renal artery fixation. Further, for theaortic section, having aortic wall movement of approximately 3 MMS perheart beat, polyester (Dacron) is the preferred covering material.Moreover, with respect to grafts used in the iliac artery sections,where there is very little wall movement, PTFE is the preferred graftcovering material. In the adjustable length portion of the extensiongraft, the graft material is crimped to permit axial or lengthwiseextension and compression thereof.

The graft apparatus includes radially compressible spring means,preferably in the form of a nitinol wire spring having a pair ofcoaxially spaced annular spring portions connected by a connecting bar,for biasing proximal and distal ends of an associated graft limb or limbportion radially outward into conforming fixed engagement with theinterior surface of the vessel. In the extension graft, an unpairedannular spring portion is located at a distal end of the adjustablelength portion for similar biasing purposes. Each wire spring isenclosed by the graft material and stitched thereto, with cut-outportions being provided between spokes of the wire spring to define aplurality of radially distensible finger portions at the ends of thegraft. A distal end of the contralateral limb of the bifurcated graft,and the distal end of the adjustable length portion of the extensiongraft, are each provided with a retainer ring to retain respectivespring portions associated therewith in a radially compressed or loadedcondition during deployment.

In a preferred embodiment, the graft apparatus further comprises aplurality of outer packets formed of a light degradable polymer andcontaining a tissue adhesive which is released by fiber-optic scopeafter the graft is implanted to bond the ends of the graft to theinterior surface of the vessel and prevent leakage through micro-crackstherebetween. Medical grade expandable foam cuffs preferably surroundthe middle portion of the graft to promote clotting within the aneurysmsac. Alternatively, light actuated cryo precipitate fibrin glue may bepainted onto the exterior surface of the graft material with a brush.The adhesive naturally remains as syrup until light actuates and cures.This replaces the need for packets and reduces the possibility ofpremature release of adhesive from packets that may break duringdeployment.

The deployment means of the present invention generally comprises anelongated sheath introducer having an axially extending sheath passagefor slidably receiving the graft and maintaining the graft andassociated spring means in a radially compressed pre-loaded conditionprior to deployment of the graft within the vessel lumen, an elongatedinsertion catheter received within the sheath passage and pre-loadedgraft for use in guiding the graft to the location of the aneurysm anddeploying the graft within the vessel lumen at such location, and aflexible condensing spring push rod slidably arranged about theinsertion catheter and received within the sheath passage to abut withthe graft for navigating through tortuous vessels and pushing the graftout of the sheath passage during deployment. Deployment means may alsocomprise a micro-emboli filter tube selectively slidable over the sheathintroducer and having controllable renal and iliac filters which may beopened to catch thrombus dislodged into the blood stream.

In one embodiment the push rod comprises a helical coil member. The pushrod in this embodiment has a continuously variable stiffness so that thepush rod may move flexibly throughout a tortuous vessel with minimalkinking of the sheath or other portions of the delivery system.

The insertion catheter of the present invention includes an embeddedkink-resistant nitinol core wire and three inner tracks extendinglengthwise thereof. A first inner track opens at both a near end and aremote end of the insertion catheter for receiving a guidewire to guidethe insertion catheter through the vessel lumen. A second inner trackopens at the near end of the insertion catheter for allowing fluidcommunication with an inflatable and deflatable tip balloon located atthe remote end of the insertion catheter for dilating the vessel aheadof the graft and controlling blood flow through the vessel duringplacement. A third inner track opens at the near end of the insertioncatheter for allowing fluid communication with an inflatable anddeflatable graft balloon located near the remote end of the insertioncatheter generally for securing the graft spring means against theinterior surface of the vessel during graft deployment.

An optional spool apparatus may also be incorporated into the deploymentmeans for collapsing a deployed graft and reloading the graft intosheath introducer 106 if unexpected leakage is observed due to incorrectgraft position or size. The spool apparatus is connected to the sheathintroducer and includes a plurality of suture loops wound around a spoolcylinder and arranged to extend through a central axial passage of thepush rod and around respective crests of a distal spring portion of thegraft. A hand crank enables rotation of the spool cylinder to collapsethe distal spring and pull it to within the sheath introducer, and ablade is provided on the spool apparatus for cutting each suture loop atone point to permit removal of the suture material if repositioning orremoval of the graft is unnecessary.

A method of surgically implanting a pre-sized single limb graft torepair a previously-mapped aortic aneurysm using the deployment means ofthe present invention may be summarized as follows, keeping in mind thatfluoroscopic or other monitoring means known in the art may be employedthroughout the procedure.

First, a guide wire is introduced into the vessel via a femoralpercutaneous entry and progressively inserted until a remote end of theguide wire extends upward past the aorto-renal junction, and theinsertion catheter with surrounding pre-loaded graft, push rod, andsheath introducer are caused to follow the guidewire through the vessellumen using the first inner track of the insertion catheter until thetip balloon is above the aorto-renal junction. The tip balloon may bepartially inflated during insertion of the deployment means to dilatethe vessel for easier introduction, and once properly positioned, may beinflated further so as to obstruct blood flow in the aorta just abovethe aorto-renal junction. With aortic blood flow obstructed, theinsertion catheter is rotated so that the sheath introducer andcompressed graft therewithin are best aligned to match the bends in thepatient's aorta. Next, the spring portion associated with the proximalend of the graft is observed for correct axial alignment within thevessel at a location just below the aorto-renal junction.

Once proper positioning and alignment of the apparatus are observed, thesheath introducer is withdrawn a short distance while holding the pushrod in place to release the proximal spring portion of the graft fromwithin a remote end of the sheath passage and allow it to expandradially outward to conform with the interior surface of the vessel,with verification being made that the proximal spring portion continuesto be in correct position. The operator may remove the guidewire fromthe first inner track and inject contrast media into the first innertrack, or may place an ultrasound imaging catheter, for purposes ofvisualization. Next, the insertion catheter is moved upward within thevessel to align the graft balloon to within the proximal spring portionof the graft, and the graft balloon is inflated with relatively highpressure to fixedly model the proximal spring portion against theinterior surface of the vessel. The sheath introducer may now bewithdrawn further to fully deploy the graft, including the distal springportion, which should be located at a healthy region below the aneurysm.

Blood flow may then be gently introduced to the graft by slowlydeflating the tip balloon. The graft balloon may be repeatedly deflated,moved incrementally along the central axis of the graft, and re-inflatedto smooth out any wrinkles in the graft material. When the graft balloonhas traveled down the graft to within the distal spring portion, it mayagain be inflated at a relatively high pressure to fix the distal springin conformance with the inner surface of the vessel. If it is observedthat the graft is not in its intended position, the spool apparatus ofthe present invention may be used to reload the graft within the sheathintroducer.

Once the graft is correctly deployed, the deployment means may becompletely withdrawn from the patient, and a fiber-optic scope insertedthrough the entry site to direct light at the tissue adhesive packets tocause the packet polymer material to degrade, thereby releasing thetissue adhesive. Finally, the entry site attended using standardprocedure. Post-operative imaging may be conducted to verify isolationof the aneurysm, with particular attention being given to the occurrenceof leaks at the proximal end of the graft closest to the heart.

The present invention also relates to a single-entry method ofsurgically implanting a pre-sized bifurcated graft in cases wheremapping of the aneurysm indicates involvement of one or both iliacvessels.

Deployment of the bifurcated graft is carried out by a method similar tothat used to implant a single-limb graft, except that additionalprocedures are required to properly implant a contralateral limb of thebifurcated graft within a contralateral iliac vessel. As the sheathintroducer is withdrawn to deploy the primary leg of the graft withinthe aorta, the contralateral limb of the graft will be released from thesheath introducer when the sheath introducer has been withdrawn justpast the graft junction, such that the contralateral limb of the graftis within the aneurysm sac or directed downward into the contralateraliliac vessel. The retainer ring at the distal end of the contralaterallimb prevents premature expansion of the spring portion associated withsuch end to permit proper positioning of the contralateral limb withinthe contralateral iliac vessel.

Positioning of the contralateral limb is carried out using the insertioncatheter and a deflectable guide wire inserted within the first innertrack of the insertion catheter and having an inflatable and deflatabletip balloon at a remote end thereof. First, the graft balloon isdeflated and the insertion catheter with inserted deflectable guide wireare withdrawn to the graft junction. A dial control may be used todeflect the remote end of the guide wire and direct it into thecontralateral limb of the graft; the guide wire is then advanced deepinto the contralateral iliac vessel and the tip balloon thereof isinflated to anchor the guide wire within the vessel. With its own tipballoon partially inflated, the insertion catheter is advanced along theanchored guide wire into the contralateral limb of the graft. Theinsertion catheter tip balloon is then inflated more fully to allow flowdirection of blood to carry graft material of the contralateral limbdown the contralateral iliac vessel. The contralateral limb is moved toa final desired location by deflating the insertion catheter tip balloonand advancing it to within the spring portion at the distal end of thecontralateral limb held by the retainer ring, partially reinflating thetip balloon to hold the distal end and associated distal spring portionof the contralateral limb by friction, advancing the insertion catheterinto the contralateral iliac vessel until the distal end of thecontralateral limb is at the desired location, and finally reinflatingthe tip balloon fully to expand or break the retainer ring and releasethe spring portion. The deployment means may then be withdrawn andremoved from the entry site and the entry site attended using standardprocedure.

If the extent of disease indicates that a longer graft limb is necessaryin either or both iliac vessels, an adjustable length extension graftmay be coaxially coupled to a lateral limb, for instance thecontralateral limb, of the bifurcated graft by the following procedure.

The extension graft is deployed via percutaneous entry through thecontralateral femoral artery. A guide wire is directed through thecontralateral limb and up into the primary limb of the bifurcated graft,and deployment means carrying a pre-loaded extension graft is directedover the guidewire to position the mating portion of the extension graftpartially within the contralateral limb of the bifurcated graft suchthat a first spring portion at the proximal end of the mating portion isoverlapped by the spring portion at the distal end of the contralaterallimb. The sheath introducer may then be withdrawn while the push rod isheld stationary to deploy the first spring portion, the insertioncatheter moved upwards to locate the graft balloon within the firstspring portion, and the graft balloon inflated to conform the firstspring portion to the interior surface of the contralateral limb.Contrast media is injected through the first inner track of theinsertion catheter to verify that the coupled graft limbs are notleaking. Next, the sheath introducer is further withdrawn to release asecond spring portion defining a junction between the mating andadjustable-length portions, and a third spring portion at a distal endof the adjustable-length portion the radially retained distal annularspring of the adjustable length portion, into the contralateral iliacvessel. The graft balloon is then deflated and moved downward to withinthe third spring portion, and partially re-inflated to hold the distalend of the adjustable-length portion by friction. This permits thedistal end of the adjustable-length portion to be positioned generallyjust above the sub-iliac or hypo-gastric branch by withdrawing theinsertion catheter downward. The third spring portion is deployed byfully reinflating the graft balloon therewithin to expand or break thesurrounding retainer ring and fix the third spring portion inconformance with the interior surface of the vessel. Any wrinkles in theextension graft may be removed using the graft balloon. Finally, onceleakage has been ruled out, such as by angiogram verification, thedeployment means may be withdrawn and the entry site attended.

BRIEF DESCRIPTION OF THE DRAWINGS

The nature and mode of operation of the present invention will now bemore fully described in the following detailed description taken withthe accompanying drawings wherein:

FIG. 1 is an elevational view showing a single-limb graft of the presentinvention fully deployed within an aorta of a patient to repair ananeurysm;

FIG. 2 is a view similar to that of FIG. 1, however showing an optionalanchor spring attached to the graft for suprarenal fixation of thegraft;

FIG. 3 is an elevational view showing a bifurcated graft of the presentinvention fully deployed within an aorta and lateral iliac vesselsjoined therewith;

FIG. 4 is a view similar to that of FIG. 3, however showing an extensiongraft of the present invention for coupling with a lateral limb of thebifurcated graft;

FIG. 5 is a perspective view showing graft deployment means of thepresent invention;

FIG. 5A is an elevational view of an alternative embodiment of a pushrod of the present invention.

FIG. 5B is an exploded elevational view of the push rod of FIG. 5A

FIG. 6 is a sectional view thereof taken generally along the line 6—6 inFIG. 5;

FIG. 7a is a perspective view showing a spool apparatus of the presentinvention;

FIG. 7b is an enlarged partial view of circled portion A in FIG. 7ashowing the arrangement of a suture loop of the spool apparatus;

FIG. 8 is an elevational view showing a micro-emboli filter tube of thepresent invention in an activated condition;

FIGS. 9a-9 d are a series of elevational views illustrating a method ofdeploying a single-limb graft in accordance with the present invention;

FIGS. 10a and 10 b are elevational views illustrating a method ofdeploying a bifurcated graft in accordance with the present invention;and

FIG. 11 is an elevational view illustrating a method of deploying anextension graft for coupling with a lateral limb of a bifurcated graftin accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring initially to FIG. 1, there is shown an aorta 10 joined byrenal arteries 12 and 14 at aorto-renal junction 16, and having ananeurysm 18 below the aorto-renal junction characterized by a weakenedand expanded vessel wall at the diseased region. In accordance with thepresent invention, an elongated single-limb tubular graft 20 is deployedat the region of aneurysm 18 as a prosthetic device for the purpose ofrelieving blood flow pressure against the weakened vessel wall by actingas a fluid conduit through the region of the aneurysm. In its deployedcondition, graft 20 defines a central longitudinal axis 22 extending ina direction of blood flow through aorta 10, and generally comprises adeformable graft material 24 enclosing radially compressible springmeans 26 for biasing a proximal end 28 and a distal end 30 of the graftinto conforming fixed engagement with an interior surface of aorta 10.

Graft material 24 is a biocompatible, flexible and expandable,low-porosity woven fabric, for example thin-walled polyester or PTFE,capable of substantially deforming to conform with an interior surfaceof aorta 10, and additionally capable of acting as a fluid conduit whenin tubular form. A middle portion 29 of graft 20 between proximal end 28and distal end 30 is tapered to provide a decreased fluid-conductingcross-sectional area relative to ends 28 and 30, such as by excising atleast one longitudinal strip of graft material 24 and sewing theresulting gap or gaps closed, as a way of reducing the occurrence offolding and wrinkling and adapting the graft to fit within a wider rangeof differently sized vessels.

Enclosed within graft material 24 is a nitinol wire spring having aproximal spring portion 34 and a distal spring portion 36.Alternatively, the proximal spring portion 34 may have uncoveredportions or open areas proximal of the graft material so that in theevent the spring portion 34 is deployed over the renal arteries 12, 14,the blood flow through arteries 12, 14 will not be blocked. Springportions 34 and 36 are designed to exert radially outward force ofapproximately 240 to 340 grams for biasing graft material 24 at graftends 28 and 30 into conforming fixed engagement with the interiorsurface of aorta 10 above and below aneurysm 18. The nitinol wire usedto form the spring is in a super elastic, straight annealed conditionand may be coated with titanium oxide to improve biocompatibility,reduce the incidence of allergic reaction to nickel, and improveradiopacity. A PTFE coating may also be used to lower the risks of bloodclotting and wire corrosion. As a further preventive measure, thecoating may be treated with iridium 192 or other low dose Beta radiationemitting substance to reduce post-surgical cell proliferation in thevessel which can lead to closure of the vessel. Spring portions 34 and36 are each formed by revolving a sinusoidal wire pattern of straightspokes 38 connected by rounded alternating crests 40 and troughs 42about central axis 22 to provide a continuous annular spring portion. Apreferred spring portion includes five equispaced crests 40 and fiveequispaced troughs 42 formed to a predetermined radius to produce betterspring properties and avoid sharp transitions in the wire, in that sharptransitions are more prone to failure. The coaxially spaced springportions 34 and 36 are connected by at least one straight connecting bar44 which preferably extends generally parallel to central axis 22 forminimal disruption of blood flow. Connecting bar 44 provides torsionalstability for graft 20, and may be welded to spring portions 34 and 36,or fastened thereto by a small tightened sleeve (not shown).

The wire spring is sewn within graft material 24 using polyester suture.Prior to sewing, graft material 24 is arranged to surround the wirespring and is heat pressed to conform to spring portions 34 and 36 usingan arcuate press surface (not shown) heated to approximately 150 degreesFahrenheit and corresponding in curvature to the spring portions. Apreferred stitch pattern includes two generally parallel stitchesextending along opposite sides of the wire, and a cross-over stitcharound the wire for pulling the parallel stitches together to achievetight attachment of graft material 24 to the wire spring. This method ofattachment substantially prevents contact between wire spring and theinterior surface of the vessel, and is reliable over time. In accordancewith the present invention, graft material 24 is cut out between crests40 of proximal spring portion 34 and distal spring portion 36 to definea plurality of radially distensible finger portions 46 at graft ends 28and 30. Importantly, finger portions 46 allow graft 20 to be situatedwith proximal end 28 much closer to aorto-renal junction 16 than waspossible with prior art graft constructions, since gaps between thefinger portions may be aligned with renal arteries 12 and 14 so as notto block blood flow. Moreover, finger portions 46 may be radiallycompressed to approximate a conical tip to facilitate loading insertionof graft 20 within a sheath introducer, to be described hereinafter. Asshown in FIG. 2, a bare nitinol wire anchor spring 48 may be used toprovide increased positional integrity to graft 20 where healthy vesselneck between aorto-renal junction 16 and aneurysm 18 is particularlyshort. Anchor spring 48 includes a proximal spring portion 50 setapproximately 20 mms above aorto-renal junction 16 for suprarenalfixation remotely of graft proximal spring portion 34, and a distalspring portion 52 sewn within graft middle portion 29 and connected toproximal spring portion 50 by at least one axially extending connectingbar 54. The provision of radially distensible finger portions 46 andoptional anchor spring 48 render the present invention useful in a muchgreater patient population relative to prior art graft systems, in thatonly about 5 mms of healthy vessel neck below the aorto-renal junctionis required as compared with about 20 mms for prior art graft systems.

Graft 20 further includes a plurality of releasable tissue adhesivepackets 56 fixed to an exterior surface of graft material 24 at ends 28and 30 for establishing a fluid tight seal between graft material 24 andthe inner wall of aorta 10. Packets 56 may be constructed ofphotosensitive polyurethane and filled with biocompatible tissueadhesive, for example fibrin glue or isobutyl 2cyanoacrylate. The tissueadhesive remains secure during deployment, and may subsequently bereleased by directing a fiber-optic catheter light source at packets 56from inside graft 20 to cause breakdown of the packet material. Tissueadhesive enters and occupies small micro-cracks existing between graftmaterial 24 and the interior surface of aorta 10 to form a bonding fluidseal, thereby preventing the serious problem of leakage. An alternativeto the described tissue adhesive packets is the use of light activatedcryo precipitate fibrin glue painted on the exterior surface of thegraft material.

In addition to tissue adhesive packets 56 at ends 28 and 30, one or morecuffs 58 comprising medical-grade expandable foam may be provided tosurround middle portion 29 to promote clotting in the space of theaneurysm outside of graft 20. In a preferred embodiment, first andsecond cuffs expandable to approximately 4-10 mms greater than the graftdiameter are arranged near spring portions 34 and 36, and a third cuffexpandable to approximately 10-40 mms greater than the graft diameter isarranged intermediate the first and second cuffs. Cuffs 58 preferablyinclude fetal endothelial cells, smooth muscle cells, or other livingtissue cells and glioma growth factor in their respective foam matricesor light activated foaming particles to encourage healing near springportions 34 and 36 and filling of aneurysmal sac 18 around middleportion 29.

A bifurcated graft 60 as shown in FIG. 3 is also within the scope of thepresent invention for use in cases where involvement of one or bothiliac vessels 11 and 13 is indicated. Graft 60 is Y-shaped and includesa primary limb 62 for location within aorta 10, and is joined by anipsilateral limb 64 for location within ipsilateral iliac vessel 11, andby a contralateral limb 66 for location within contralateral iliacvessel 13, at a graft junction 63. Each limb of bifurcated graft 60 isgenerally similar in construction to single-limb graft 20 in that theproximal and distal ends of each limb are biased into conforming fixedengagement with the interior surface of a corresponding vessel byannular spring portions associated therewith, and middle portions ofeach limb are preferably tapered. A first nitinol wire spring isenclosed by, and attachably sewn within, graft material 24 and includesa proximal spring portion 68A associated with a proximal end of primarylimb 62, a distal spring portion 68B associated with a distal end ofprimary limb 62, and an axially extending connecting bar 68C couplingthe proximal and distal spring portions together. Similarly, a secondnitinol wire spring having a proximal spring portion 70A, a distalspring portion 70B, and an axially extending connecting bar 70C, is sewnwithin ipsilateral limb 64; and a third nitinol wire spring having aproximal spring portion 72A, a distal spring portion 72B, and an axiallyextending connecting bar 72C, is sewn within contralateral limb 66.Terminal ends of bifurcated graft 60, namely the proximal end of primarylimb 62 and the distal ends of lateral limbs 64 and 66, are providedwith radially distensible finger portions 46 as described above. Whereentry is to be made through an ipsilateral femoral artery to deploygraft 60, distal spring portion 72B is held in a radially compressedcondition by an expandable retainer ring 79, which may simply be alength of suture material tied end to end using a purse-string type knotto form a loop, to prevent premature deployment of distal spring portion72B prior to proper positioning thereof within contralateral iliacvessel 13. Likewise, where entry is to be made through a contralateralfemoral artery, distal spring portion 70B may be provided with aretainer ring 79 to prevent premature deployment of distal springportion 70B prior to proper positioning thereof within ipsilateral iliacvessel 11. It will be understood that previously described tissueadhesive packets 56 and foam cuffs 58, while not shown in FIG. 3, may beincorporated into bifurcated graft 60. Specifically, packets 56 arepreferably provided at least at the proximal end of primary limb 62 toprevent leaking, and foam cuffs 58 are preferably provided around theprimary limb for filling aneurysmal sac 18.

A single-limb extension graft 80, as depicted in FIG. 4, embodiesanother useful apparatus of the present invention. Extension graft 80 isdesigned for end-to-end coupling with a lateral limb of bifurcated graft60, for example contralateral limb 66, and generally includes a matingportion 82 and an adjustable length portion 84 extending coaxially froma distal end of the mating portion. Mating portion 82 includes a wirespring having a first spring portion 88A serving to bias a proximal endof mating portion 82 into conforming fixed engagement with an interiorsurface of contralateral limb 66, and a second spring portion 88Bconnected to first spring portion 88A by a connecting bar 88C serving tobias a distal end of mating portion 82 and a proximal end of adjustablelength portion 84 into conforming fixed engagement with the interiorsurface of contralateral iliac vessel 13. An unpaired third springportion 90 is provided at a distal end of adjustable length portion 84to bias such end against the interior surface of contralateral iliacvessel 13, and is maintained in a radially compressed condition prior todeployment by a breakable retainer ring 91 similar to retainer ring 79.Third spring portion 90 is movable in opposite axial directions to adesired location during deployment by virtue of a crimped length ofgraft material provided in adjustable length portion 84.

As will be appreciated by those skilled in the art, the above describedgrafts 20, 60, and 80 may be manufactured in a range of sizes forfitting within differently sized vessels to repair aneurysms of variouslengths.

A preferred apparatus of the present invention for deploying a graftwithin a blood vessel is depicted in FIGS. 5 and 6 and identifiedgenerally by the reference numeral 100. Deployment means 100 iselongated to permit delivery of a graft carried thereby to aneurysm 18via percutaneous entry into a femoral artery of the patient, and may bedescribed as having a near end 102 normally remaining outside the skinof the patient for manipulation by an operating surgeon, and a remoteend 104 normally traveling inside the blood vessel lumen duringdeployment and carrying a graft to be implanted at aneurysm 18.Deployment means 100 includes an elongated sheath introducer 106 havingan axially extending sheath passage 108; an elongated insertion catheter110 loosely received within sheath passage 108; and an elongatedcompression spring push rod 112 slidably mounted over insertion catheter110 and received within sheath passage 108.

Sheath introducer 106 is formed of a low-friction, flexible material,preferably F.E.P., however polyurethane, silicone, polyethylene, orother similar materials may be substituted for PTFE. The size of sheathintroducer 106 is chosen based on the size of the graft to be deployedso as to hold the graft within a remote end of sheath passage 108 in aradially compressed, pre-loaded condition prior to deployment of thegraft within the vessel, with sizes 12 FR, 14 FR, 16 FR, 18 FR, and 20FR being suitable in a vast majority of instances. Graft finger portions46 can be pushed together to approximate a conical tip for easierinsertion of graft 20 within sheath passage 108, a feature which hasresulted a 2 FR reduction in sheath introducer profile relative toloading a similar graft without finger portions 46. In order to permitviewing of a pre-loaded graft to confirm proper loading, sheathintroducer 106 is preferably transparent. Sheath introducer 106 isequipped with at least one latex-lined hemostasis valve 114 at a nearend thereof serving to form a fluid seal around push rod 112 to preventblood from leaking out of the patient at the entry site. A side portmeans 116 is provided for transporting fluid, such as heparinizedsolution or contrast media, into sheath passage 108 and eventually intothe blood vessel. Side port means 116 includes a manually operable valve118 communicating with sheath passage 108 through a flexible tube 120and adapted to receive a suitable fluid injection means (not shown).

Insertion catheter 110, which may be formed of 8 FR catheter tubing, islonger than sheath introducer 106 to permit near and remote ends thereofto extend from sheath introducer 106 when the insertion catheter isreceived within sheath passage 108. As seen in the cross-sectional viewof FIG. 6, insertion catheter 110 is provided with an embedded,kink-resistant nitinol core wire 122, a first inner track 124, a secondinner track 126, and a third inner track 128, all extending lengthwisethereof. Referring once again to FIG. 5, a first end port means 130 fortransporting fluid to first inner track 124 includes a threaded adapter132 for mating with suitable fluid injection means (not shown) andcommunicating with a near end of first inner track 124 through aflexible tube 134. A second end port means 136 for transporting fluid tosecond inner track 126 includes a manually operable valve 138communicating with a near end of the second inner track through aflexible tube 140 and adapted to receive a suitable fluid injectionmeans 142. Similarly, a third end port means 144 for transporting fluidto third inner track 128 includes a manually operable valve 146communicating with a near end of the third inner track through aflexible tube 148 and adapted to receive a suitable fluid injectionmeans 150.

In a preferred form of the invention, core wire 122 is gradually taperedfrom a diameter of 0.031 inches at the near end of insertion catheter110 to a diameter of 0.020 inches at the remote end of the insertioncatheter. This feature provides that the near end of insertion catheter110 is strong, and the remote end of the insertion catheter is lesslikely to cause puncture or rupture of the vessel yet will not deflectsignificantly under force of blood flow. In addition to providing kinkresistance and strength to insertion catheter 110, core wire 122provides greatly improved torsional rigidity, whereby rotation at thenear end of insertion catheter 110 about its longitudinal axistranslates into a substantially equivalent rotation at the remote end ofthe insertion catheter, such that a graft may be easily rotated duringdeployment for proper alignment.

In accordance with the present invention, second inner track 126communicates with a transparent polyurethane tip balloon 152 arrangedcircumferentially about insertion catheter 110 at the remote endthereof, while third inner track 128 communicates with a transparentpolyurethane graft balloon 154 arranged circumferentially aboutinsertion catheter 110 in the vicinity of tip balloon 152. Balloons 152and 154 are preferably of the same outside diameter or profile whenfully inflated, with graft balloon 154 being longer than tip balloon152. Balloons 152 and 154 behave in a pressure compliant manner, suchthat the profile thereof may be continuously and reversibly varied bychanging inflation pressure using fluid injection means 142 and 150,respectively. Fluid injection means may be a syringe having a slidableplunger for observably varying a plenum volume of the syringe, and theplenum volume may be functionally correlated with balloon profilediameter. A preferred inflation fluid is filtered carbon dioxide, whichis readily visualized by X-ray observation.

Insertion catheter 110 further includes a tapered head 156 adjacent tipballoon 152 for providing a rigid vessel dilator characterized by asmooth atraumatic transition from an 8 FR profile of the insertioncatheter to a larger profile of sheath introducer 106. Tapered head 156preferably defines an annular abutment lip 158 arranged to engage theremote end of sheath introducer 106 to prevent withdrawal of the taperedhead to within sheath passage 108. Insertion catheter 110 may also beprovided with a plurality of circumferential radiopaque markings (notshown) equispaced along the length thereof to assist in location of theinsertion catheter during deployment of a graft.

Push rod 112 is a metallic compression spring having a combination offlexibility and axial compression strength to enable it to follow thepath of a tortuous vessel without losing its ability to act as a pushrod for exerting force against a graft during deployment. Push rod issized with inner clearance relative to insertion catheter 110 and outerclearance relative to sheath introducer 106 so as to be independentlymovable within sheath passage 108. A plunger 162 is preferably arrangedat remote end of push rod 112 for stopping blood flow within sheathpassage 108. Push rod 112 may also include dampening means near itsremote end, such as a thin heat-shrunken polyolifin or polyimid coating,to dampen undesirable recoil of the push rod.

FIGS. 5a and 5 b illustrate another embodiment of a push rod apparatusto be used in place of push rod 112 as part of deployment means 100.Push rod 312 comprises a handle 313 located towards the proximal or nearend 102 of the deployment means 100, coupled to a push rod body 317,which is in turn coupled to a helical coil portion 320. A cup 322 islocated at the distal end of the helical coil portion 320 for containingthe distal portion of the stent held within the sheath passage 108.

The handle 313 includes a luer adaptor 314 for coupling with a TuohyBorst connector (not shown), a lumen 315 extending through the handle313 for receiving insertion catheter 110, and a female connectingportion 316 for receiving push rod body 317 and push rod stiffener 318.

The push rod body 317 extends distally or remotely of the handle 313 andis made of a polymer material such as polyethylene. Push rod body 317has lumen 319 extending through the body for receiving the introducercatheter 110 and push rod stiffener 318. Push rod stiffener 318 and pushrod body 317 are coupled to the handle 313 through female connectingportion 316. Push rod stiffener 318 provides further support for theflexible push rod body 317 during deployment of the graft. The handle313 is used in deploying the graft by holding the graft in place whilethe sheath covering the graft is retracted.

The distal end of the push rod body 317 is coupled to the helical coilportion 320. The helical coil portion 320 is preferably made of ahelically wound metal material such as stainless steel. The helical coilportion 320 includes an inner spring 323 threaded inside the helicalcoil portion 320 at the juncture between the helical coil portion 320and the push rod body 317. The inner spring 323 provides for atransition in stiffness between the relatively stiffer push rod body 317and the more flexible helical coil portion 320. The inner spring 323provides a relatively smooth or continuous transition in stiffness fromthe push rod body 317 to the helical coil portion 320. In thisembodiment, the transition occurs from a stiffer push rod body to a moreflexible coil.

At the distal end of the helical coil portion 320, a cup 322 is threadedinto the lumen 321 through the helical coil portion 320. The cup opening327 is arranged to receive the distal portion of the graft containedwithin the sheath passage 108. The cup portion 322 acts to minimizekinking of the sheath that occurs because of the discontinuity instiffness between the push rod and the graft. The cup portion 322enables the push rod 312 and graft to act as one unit during deployment.Other means for holding or containing the prostheses are contemplated bythis invention. This would include any structure that holds theprosthesis in a position adjacent the push rod so that the push rod andprosthesis act relatively as a unit during deployment or so that kinkingof the sheath is decreased. Examples of such structures may includehooks ribbons, wires and posts that engage either the inner or outerlumen of the prosthesis.

Helical coil portion 320, inner spring 323, and cup, 322 have lumens321,325,326 respectively therethrough. Lumens 321,325,326,315, and 319provide a continuous opening for receiving insertion catheter 110.

FIGS. 7a and 7 b illustrate an optional spool apparatus 170 provided aspart of deployment means 100 for collapsing a deployed graft andreloading the graft into sheath introducer 106 if unexpected leakage isobserved due to incorrect graft position or size. Spool apparatus 170 ismounted adjacent a near end of sheath introducer 106 by a mounting arm172, and includes a plurality of suture loops 174 wound around a spoolcylinder 176 thereof and arranged to extend through a central axialpassage of push rod 112 and around respective crests 40 of a distalspring portion of the graft, as depicted in FIG. 7b. A hand crank 178and releasable pawl (not shown) are provided for rotating and fixingspool cylinder 176 of spool apparatus 170. A blade 180 is mounted on thebody of the spool apparatus for selectively and simultaneously cuttingeach suture loop 174 at one point to enable removal thereof. Whereoptional spool apparatus 170 is provided, plunger 162 at the remote endof push rod 112 must be omitted to permit suture loops 174 to connectwith the distal spring portion of the graft.

FIG. 8 shows a micro-emboli filter tube 182 available for use withdeployment means 100 of the present invention for trapping thrombusdislodged during manipulation of deployment means 100 within the vessel.Filter tube 182 is adapted to slide over sheath introducer 106 andincludes a renal filter 184 and an iliac filter 186. Filters 184 and 186are of similar construction and include a plurality of flexible spokes188 defined by a series of axially extending slits spaced around thecircumference of filter tube 182. Nylon mesh fabric 190 is affixedaround the bottom portion of spokes 188, such that when filter tube 182is axially compressed by pushing a near end thereof while a remote endthereof is held in place by inflated tip balloon 152, spokes 188 flexradially outward to form mesh fabric 190 into a bowl-shaped filter fortrapping thrombus entering through gaps between the upper portions ofspokes 188. The near end of filter tube 182 may be pulled while theremote end remains fixed to collapse filters 184 and 186 in preparationfor the removal of filter tube 182 from the patient.

Reference is now made to FIGS. 9a-9 d, which illustrate a method ofsurgically deploying single-limb graft 20. It is assumed that necessarymapping of the vessel and aneurysm 18 have been performed, and that anappropriately sized graft 20 has been selected and pre-loaded within aremote end of sheath passage 108 of appropriately sized deployment means100. It is further assumed that certain equipment used for monitoringand visualization purposes is available for use by a surgeon skilled inthe art, including a freely positionable C-arm having high resolutionfluoroscopy, high quality angiography, and digital subtractionangiography capabilities.

As an initial step, the largest femoral artery, left or right, isdetermined by placing a high flow pig tail angiography catheter (notshown) through a percutaneous entry site in aorta 10 above aorto-renaljunction 16 and taking an angiogram; the pig tail catheter is left inplace. A flexible guide wire 200 preferably having a tip balloon (notshown) at its remote end is introduced into the vessel via apercutaneous entry site in the larger femoral artery, and progressivelyadvanced upward until its tip balloon is above aorto-renal junction 16.Deployment means 100, pre-filled with heparinized solution through sideport means 116, may then be introduced through the femoral entry siteand caused to follow guide wire 200 by inserting a near end of the guidewire into first inner track 124 via first end port means 130, and slowlyadvancing deployment means 100 upward to the site of aneurysm 18. Duringadvancement of deployment means 100 along guide wire 200, it isadvantageous to maintain tip balloon 152 partially inflated with carbondioxide for brighter visualization and atraumatic dilation of thevessel. In order to verify the position of renal arteries 12 and 14,contrast media is injected through first end port means 130 to theremote end opening of first inner track 124 above the renal arteries. Atthis point, deployment means 100 should be positioned such that proximalspring portion 34 is at or just below renal arteries 12 and 14, anddistal spring portion 36 is above the bifurcated aorto-iliac junctionand not within aneurysm 18. Blood flow through the region can beobstructed by inflating tip balloon 152 more fully using fluid injectionmeans 142 so as to occlude aorta 10, as depicted in FIG. 9a. With aorticblood flow obstructed, deployment means 100 is rotated so that sheathintroducer 106 and compressed graft 20 carried thereby are best alignedto match the bends in the patient's aorta.

Deployment of proximal spring portion 34 is initiated by withdrawingsheath introducer 106 a short distance, approximately 3.5 cm, whilesimultaneously holding push rod 112 stationary. The finger portions 46associated with proximal spring portion 34 will distend as the proximalspring portion is released from within sheath passage 108, and willappear as shown in FIG. 9b. Insertion catheter 110 is then advancedupward to position graft balloon 154 within recently deployed proximalspring portion 34, and the position and alignment of the proximal springportion relative to renal arteries 12 and 14 is verified by furtherinjection of contrast media through first end port means 130. Onceproper verification has been made, graft balloon 154 is inflated to arelatively high pressure to create a smooth vessel wall seat forproximal spring portion 34 and forcibly model the spring portion intoconforming fixed engagement with the interior surface of aorta 10without causing inelastic deformation of the spring portion, as can beseen in FIG. 9c.

With inflated graft balloon 154 reinforcing fixation of proximal springportion 34, sheath introducer 106 is further withdrawn to a point justbefore that which is required to release distal spring portion 36 fromwithin sheath passage 108. Once verification has been made that distalspring portion 36 is not going to block either ipsilateral iliac vessel11 or contralateral iliac vessel 13, sheath introducer may be withdrawna distance sufficient to release distal spring portion 36 from withinsheath passage 108, as depicted in FIG. 9d.

Blood flow may then be gently introduced to the newly deployed graft 20by slowly deflating the graft balloon 154 in small increments. Graftballoon 154 may be repeatedly deflated, moved downward through graft 20by increments of approximately 2 cm, and re-inflated to smooth out anywrinkles in graft material 24. After graft balloon 154 has traveleddownward through graft 20 to within distal spring portion 36, it mayagain be inflated to a relatively high pressure to fix the distal springportion in conformance with the interior surface of the vessel. As willbe appreciated, expandable foam sleeves 58 (shown in FIG. 1 only)surrounding middle portion 29 act to promote clotting in an aroundaneurysm 18.

If graft 20 is observed to be incorrectly placed and optional spoolapparatus 170 has been provided, hand crank 178 thereof may be rotatedvery slowly in a counterclockwise direction as viewed in FIG. 7a tocollapse distal spring portion 36 of graft 20 and reload graft 20 backto within sheath passage 108. The sheath may be pushed upward duringreloading of graft 20 to reestablish an abutment seal between annularabutment lip 158 of tapered head 156 and the remote end of sheathintroducer 106. Deployment means 100 may then be gently withdrawn,preferably after partially inflating tip balloon 152 with contrastmedia, such as carbon dioxide, for visualization. Verification that theremoval process has not caused rupture of the vessel or embolizationshould be undertaken by way of an angiogram through the previouslyplaced pig tail catheter.

Once graft 20 is correctly deployed, deployment means 100 and guide wire200 may be completely withdrawn from the patient and the entry siteattended using standard procedure. Where optional spool apparatus 170 isused, suture loops 174 may be removed by cutting them with blade 180 androtating hand crank 178 in a counterclockwise direction. Tissue adhesivemay then be released from light-degradable packets 56 (shown in FIG. 1only) by insertion of a fiber optic catheter (not shown) through thefemoral artery to graft 20 and direction of light at the packets,thereby helping to bond the graft to the vessel and seal micro-crackswhich are a source of leakage. Post-operative CAT scan and ultrasoundimaging may be conducted to verify isolation of the aneurysm, withparticular attention being given to the occurrence of leaks at proximalspring portion 34 closest to the heart.

Referring now to FIGS. 10a and 10 b, a single-entry method for deployingbifurcated graft 60 in accordance with the present invention isprocedurally similar to the method described above with regard tosingle-limb graft 20, however additional steps are necessary to deploycontralateral limb 66 within contralateral iliac vessel 13 with the helpof a deflectable-tip guide wire 206 used in place of regular guide wire200 and having a controllable balloon 208 at a remote end thereof.Bifurcated graft 60 is pre-loaded into sheath passage 108 withcontralateral limb 66 folded alongside primary limb 62, such that assheath introducer 106 is withdrawn past graft junction 63 subsequent todeployment of proximal spring portion 68A, contralateral limb 66 unfoldsgenerally into aneurysm 18 or the mouth of contralateral iliac vessel13, as shown in FIG. 10a. Retainer ring 79 prevents premature expansionof distal spring portion 72B, thereby enabling distal spring portion 72Bto be moved within contralateral iliac vessel 13 to a proper positionfor deployment.

To position distal spring portion 72B, graft balloon 154 is deflated andinsertion catheter 110 with inserted deflectable guide wire 206 arewithdrawn to the graft junction 63. A dial control (not shown) may beused to deflect the remote end of guide wire 206 and direct it intocontralateral limb 66 of graft 60. Guide wire 206 may then be advanceddeep into contralateral iliac vessel 13, and tip balloon 208 inflatedsufficiently to fix the guide wire within the vessel. With its own tipballoon 152 partially inflated, insertion catheter 110 is advanced alongfixed guide wire 206 into contralateral limb 66 between proximal springportion 72A and distal spring portion 72B, after which the insertioncatheter tip balloon 152 is inflated more fully to allow flow directionof blood to carry graft is material 24 of the contralateral limbdownward into contralateral iliac vessel 13. The distal end ofcontralateral limb 66 is moved to a final desired location by deflatingthe insertion catheter tip balloon 152 and advancing it to within distalspring portion 72B held by retainer ring 79, partially and carefullyre-inflating tip balloon 152 to hold distal spring portion 72B byfriction without breaking retainer ring 79, advancing insertion catheter110 further into contralateral iliac vessel 13 until the distal end ofcoritralateral limb 66 is at the desired location, and finallyreinflating the tip balloon to a pressure sufficient to expand or breakretainer ring 79 and release distal spring portion 72B, as shown in FIG.10b. Deployment means 100 may then be withdrawn and removed from thepatient and the entry site attended using standard procedure.

A method of coaxially coupling extension graft 80 to contralateral limb66 in accordance with the present invention is once again similar to themethod described above with regard to single-limb graft 20. While thepresent method is described herein for coupling extension graft 80 withcontralateral limb 66, it will be understood that a similar proceduremay be followed to deploy extension graft 80 in coupled relation withipsilateral limb 64.

Referring to FIG. 11, extension graft 80 is deployed via percutaneousentry through the contralateral femoral artery. A guide wire 200 havinga controllable tip balloon 202 is advanced upward through contralaterallimb 66 and into primary limb 62 of previously deployed bifurcated graft60, and deployment means 100 carrying pre-loaded extension graft 80 isdirected over guide wire 200, again using first inner track 124, andadvanced to a position wherein mating portion 82 of extension graft 80is partially within contralateral limb 66, preferably with first springportion 88A of mating portion 82 overlapped by distal spring portion 72Bof bifurcated graft 60. Sheath introducer 106 is then withdrawn whilepush rod 112 is held stationary in order to release first spring portion88A. To set first spring portion 88A into conforming coupled engagementwith an interior surface of contralateral limb 66, insertion catheter110 is advanced upwards to locate graft balloon 154 within first springportion 88A, and the graft balloon is inflated to a relatively highpressure. Contrast media may then be injected as previously described toverify that the coupled graft limbs are not leaking.

Next, sheath introducer 106 is further withdrawn to successively releasesecond spring portion 88B and third spring portion 90 from sheathpassage 108, with third spring portion 90 remaining in a compressedcondition due to retainer ring 91. Graft balloon 154 is then deflatedand moved downward to within third spring portion 90, and partiallyre-inflated to hold the third spring portion by friction, with carebeing taken so as not to overinflate graft balloon 154 and expand orbreak retainer ring 91. This permits the distal end of adjustable lengthportion 84 to be positioned generally just above the sub-iliac orhypogastric branch by further withdrawing insertion catheter 110. Thirdspring portion 90 is deployed by inflating graft balloon 154 therewithinto a relatively high pressure sufficient to expand or break surroundingretainer ring 91, as depicted in FIG. 11, and fix the third springportion in conformance with the interior surface of contralateral iliacvessel 13. Any wrinkles in extension graft 80 may be removed using graftballoon 154 as previously described herein. Finally, once leakage hasbeen ruled out, such as by angiogram verification, deployment means 100may be withdrawn from the patient and the entry site attended.

It is contemplated herein that the delivery system of the presentinvention and in particular the aspects regarding the flexible,compressible push rod may be used in deploying other endoluminalprostheses where the prosthesis is retained in the shaft of a catheterfor delivery to an endoluminal site. Endoluminal prostheses which termsare herein intended to mean medical devices which are adapted fortemporary or permanent implantation within a body lumen, including bothnaturally occurring or artificially made lumens. Examples of lumens inwhich endoluminal prostheses may be implanted include, withoutlimitation: arteries such as those located within coronary, mesentery,peripheral, or cerebral vasculature; veins; gastrointestinal tract;biliary tract; urethra; trachea; hepatic shunts; and fallopian tubes.Various types of endoluminal prostheses have also been developed, eachproviding a uniquely beneficial structure to modify the mechanics of thetargeted luminal wall.

What is claimed is:
 1. An endoluminal prosthesis comprising: a graft;means for attaching the graft within a vessel; and medical gradeexpandable foam cuffs that are independent of and displaced from theattachment means and positioned surrounding the graft.
 2. Theendoluminal prosthesis of claim 1, wherein said cuffs include livingtissue cells.
 3. The endoluminal prosthesis of claim 1, wherein saidcuffs include fetal endothelial cells.
 4. The endoluminal prosthesis ofclaim 1, wherein said cuffs include smooth muscle cells.
 5. Theendoluminal prosthesis of claim 1, wherein said cuffs include gliomagrowth factor.
 6. The endoluminal prosthesis of claim 1 furthercomprising: a light actuated cryo precipitate fibrin glue disposed on anexterior surface of said graft.
 7. An endoluminal prosthesis comprising:a graft; and a plurality of packets containing a biocompatible tissueadhesive, wherein said packets are fixed to an exterior surface of saidgraft.
 8. The endoluminal prosthesis of claim 7, wherein said packetsare formed of a light degradable polymer.
 9. The endoluminal prosthesisof claim 7, wherein said packets are constructed of photosensitivepolyurethane.
 10. The endoluminal prosthesis of claim 7, wherein saidbiocompatible tissue adhesive is fibrin glue.
 11. The endoluminalprosthesis of claim 7, wherein said biocompatible tissue adhesive isisobutyl 2-cyanoacrylate.
 12. An endoluminal prosthesis comprising: agraft having a proximal end and a distal end; means for attaching saidgraft within a vessel, wherein said means for attaching secures at leastsaid proximal end of said graft within the vessel; and a wire anchorspring including a proximal spring portion and a distal spring portionconnected to said proximal spring portion by an axially extendingconnecting bar, wherein said proximal spring portion is positionedremotely of said proximal end of said graft and said distal springportion is positioned within said graft distally of said means forattaching said proximal end of said graft to the vessel.